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Tecnologia·Business

FDA approves Grace Therapeutics’ GTx-104?

Market icon
Tecnologia·Business

FDA approves Grace Therapeutics’ GTx-104?

apr 23

apr 23

apr 23

apr 23

70% probabilità
Polymarket
NUOVO
70% probabilità
Polymarket
NUOVO
As of market creation, the FDA’s expected decision date for the specified application is April 23, 2026. This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants full or conditional approval for Grace Therapeutics’ GTx-104 as a treatment for aneurysmal subarachnoid hemorrhage by May 7, 2026, 11:59 PM ET. Otherwise, this market will resolve to "No." An approval is defined as: For new drugs: FDA issuance of an approval letter for a New Drug Application (NDA) or Biologics License Application (BLA) For already-marketed drugs seeking new indications: FDA approval of a supplemental NDA (sNDA) or supplemental BLA (sBLA) for the specific indication referenced For generic drugs: FDA approval of an Abbreviated New Drug Application (ANDA) For biosimilars: FDA approval of a 351(k) application The following constitute qualifying approvals: Standard approval (traditional approval based on clinical benefit), Accelerated approval (based on surrogate endpoints), Approval with Risk Evaluation and Mitigation Strategy (REMS), Approval with restricted distribution or indication limitations, except compassionate use/expanded access programs The following do not constitute qualifying approvals: Approvable letters that require additional actions before approval Tentative approvals pending patent or exclusivity expiration FDA requests for additional information or studies Extension of Prescription Drug User Fee Amendments dates Approval for compassionate use or expanded access programs only Approval only for export or for use outside the United States Emergency Use Authorization (EUA) without full approval Complete Response Letters (CRLs) indicating the application cannot be approved in its current form This market will immediately resolve to "No" if the FDA issues a Complete Response Letter (CRL) or explicitly declines to approve the application. If the drug sponsor withdraws the application before the end of the specified period, the market will resolve to "No" immediately. If the listed drug is approved before the end of the specified period, the market will resolve to "Yes," regardless of potential Advisory Committee votes against approval or later withdrawal of approval. Conditional approvals may include post-marketing requirements or commitments and still qualify. The primary resolution source will be official information from the FDA; however, a consensus of credible reporting will also be used.Trader consensus on Polymarket prices FDA approval of Grace Therapeutics' GTx-104—an intravenous nimodipine formulation for aneurysmal subarachnoid hemorrhage (aSAH)—at 69.5% "Yes," driven by the imminent PDUFA target date of April 23, 2026, now just six days away. Recent reinforcement came on April 14 when the company announced acceptance of its STRIVE-ON Phase 3 abstract for presentation at AAN 2026, underscoring the trial's primary endpoint success: a 19% reduction in clinically significant hypotension versus oral nimodipine, plus secondary benefits like higher dose intensity, 29% more favorable 90-day outcomes, and shorter ICU stays. Orphan Drug Designation and FDA's prior NDA acceptance signal strong positioning in an unmet need area untouched by innovation in decades, though a minor mortality imbalance tempers full certainty ahead of the decision.

As of market creation, the FDA’s expected decision date for the specified application is April 23, 2026.

This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants full or conditional approval for Grace Therapeutics’ GTx-104 as a treatment for aneurysmal subarachnoid hemorrhage by May 7, 2026, 11:59 PM ET. Otherwise, this market will resolve to "No."

An approval is defined as:
For new drugs: FDA issuance of an approval letter for a New Drug Application (NDA) or Biologics License Application (BLA)
For already-marketed drugs seeking new indications: FDA approval of a supplemental NDA (sNDA) or supplemental BLA (sBLA) for the specific indication referenced
For generic drugs: FDA approval of an Abbreviated New Drug Application (ANDA)
For biosimilars: FDA approval of a 351(k) application

The following constitute qualifying approvals:
Standard approval (traditional approval based on clinical benefit), Accelerated approval (based on surrogate endpoints), Approval with Risk Evaluation and Mitigation Strategy (REMS), Approval with restricted distribution or indication limitations, except compassionate use/expanded access programs

The following do not constitute qualifying approvals:
Approvable letters that require additional actions before approval
Tentative approvals pending patent or exclusivity expiration
FDA requests for additional information or studies
Extension of Prescription Drug User Fee Amendments dates
Approval for compassionate use or expanded access programs only
Approval only for export or for use outside the United States
Emergency Use Authorization (EUA) without full approval
Complete Response Letters (CRLs) indicating the application cannot be approved in its current form

This market will immediately resolve to "No" if the FDA issues a Complete Response Letter (CRL) or explicitly declines to approve the application. If the drug sponsor withdraws the application before the end of the specified period, the market will resolve to "No" immediately.

If the listed drug is approved before the end of the specified period, the market will resolve to "Yes," regardless of potential Advisory Committee votes against approval or later withdrawal of approval.

Conditional approvals may include post-marketing requirements or commitments and still qualify.

The primary resolution source will be official information from the FDA; however, a consensus of credible reporting will also be used.
Volume
$109
Data di fine
23 apr 2026
Mercato aperto
Apr 16, 2026, 8:45 PM ET

Resolver

0x65070BE91...
As of market creation, the FDA’s expected decision date for the specified application is April 23, 2026. This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants full or conditional approval for Grace Therapeutics’ GTx-104 as a treatment for aneurysmal subarachnoid hemorrhage by May 7, 2026, 11:59 PM ET. Otherwise, this market will resolve to "No." An approval is defined as: For new drugs: FDA issuance of an approval letter for a New Drug Application (NDA) or Biologics License Application (BLA) For already-marketed drugs seeking new indications: FDA approval of a supplemental NDA (sNDA) or supplemental BLA (sBLA) for the specific indication referenced For generic drugs: FDA approval of an Abbreviated New Drug Application (ANDA) For biosimilars: FDA approval of a 351(k) application The following constitute qualifying approvals: Standard approval (traditional approval based on clinical benefit), Accelerated approval (based on surrogate endpoints), Approval with Risk Evaluation and Mitigation Strategy (REMS), Approval with restricted distribution or indication limitations, except compassionate use/expanded access programs The following do not constitute qualifying approvals: Approvable letters that require additional actions before approval Tentative approvals pending patent or exclusivity expiration FDA requests for additional information or studies Extension of Prescription Drug User Fee Amendments dates Approval for compassionate use or expanded access programs only Approval only for export or for use outside the United States Emergency Use Authorization (EUA) without full approval Complete Response Letters (CRLs) indicating the application cannot be approved in its current form This market will immediately resolve to "No" if the FDA issues a Complete Response Letter (CRL) or explicitly declines to approve the application. If the drug sponsor withdraws the application before the end of the specified period, the market will resolve to "No" immediately. If the listed drug is approved before the end of the specified period, the market will resolve to "Yes," regardless of potential Advisory Committee votes against approval or later withdrawal of approval. Conditional approvals may include post-marketing requirements or commitments and still qualify. The primary resolution source will be official information from the FDA; however, a consensus of credible reporting will also be used.
As of market creation, the FDA’s expected decision date for the specified application is April 23, 2026. This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants full or conditional approval for Grace Therapeutics’ GTx-104 as a treatment for aneurysmal subarachnoid hemorrhage by May 7, 2026, 11:59 PM ET. Otherwise, this market will resolve to "No." An approval is defined as: For new drugs: FDA issuance of an approval letter for a New Drug Application (NDA) or Biologics License Application (BLA) For already-marketed drugs seeking new indications: FDA approval of a supplemental NDA (sNDA) or supplemental BLA (sBLA) for the specific indication referenced For generic drugs: FDA approval of an Abbreviated New Drug Application (ANDA) For biosimilars: FDA approval of a 351(k) application The following constitute qualifying approvals: Standard approval (traditional approval based on clinical benefit), Accelerated approval (based on surrogate endpoints), Approval with Risk Evaluation and Mitigation Strategy (REMS), Approval with restricted distribution or indication limitations, except compassionate use/expanded access programs The following do not constitute qualifying approvals: Approvable letters that require additional actions before approval Tentative approvals pending patent or exclusivity expiration FDA requests for additional information or studies Extension of Prescription Drug User Fee Amendments dates Approval for compassionate use or expanded access programs only Approval only for export or for use outside the United States Emergency Use Authorization (EUA) without full approval Complete Response Letters (CRLs) indicating the application cannot be approved in its current form This market will immediately resolve to "No" if the FDA issues a Complete Response Letter (CRL) or explicitly declines to approve the application. If the drug sponsor withdraws the application before the end of the specified period, the market will resolve to "No" immediately. If the listed drug is approved before the end of the specified period, the market will resolve to "Yes," regardless of potential Advisory Committee votes against approval or later withdrawal of approval. Conditional approvals may include post-marketing requirements or commitments and still qualify. The primary resolution source will be official information from the FDA; however, a consensus of credible reporting will also be used.Trader consensus on Polymarket prices FDA approval of Grace Therapeutics' GTx-104—an intravenous nimodipine formulation for aneurysmal subarachnoid hemorrhage (aSAH)—at 69.5% "Yes," driven by the imminent PDUFA target date of April 23, 2026, now just six days away. Recent reinforcement came on April 14 when the company announced acceptance of its STRIVE-ON Phase 3 abstract for presentation at AAN 2026, underscoring the trial's primary endpoint success: a 19% reduction in clinically significant hypotension versus oral nimodipine, plus secondary benefits like higher dose intensity, 29% more favorable 90-day outcomes, and shorter ICU stays. Orphan Drug Designation and FDA's prior NDA acceptance signal strong positioning in an unmet need area untouched by innovation in decades, though a minor mortality imbalance tempers full certainty ahead of the decision.

As of market creation, the FDA’s expected decision date for the specified application is April 23, 2026.

This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants full or conditional approval for Grace Therapeutics’ GTx-104 as a treatment for aneurysmal subarachnoid hemorrhage by May 7, 2026, 11:59 PM ET. Otherwise, this market will resolve to "No."

An approval is defined as:
For new drugs: FDA issuance of an approval letter for a New Drug Application (NDA) or Biologics License Application (BLA)
For already-marketed drugs seeking new indications: FDA approval of a supplemental NDA (sNDA) or supplemental BLA (sBLA) for the specific indication referenced
For generic drugs: FDA approval of an Abbreviated New Drug Application (ANDA)
For biosimilars: FDA approval of a 351(k) application

The following constitute qualifying approvals:
Standard approval (traditional approval based on clinical benefit), Accelerated approval (based on surrogate endpoints), Approval with Risk Evaluation and Mitigation Strategy (REMS), Approval with restricted distribution or indication limitations, except compassionate use/expanded access programs

The following do not constitute qualifying approvals:
Approvable letters that require additional actions before approval
Tentative approvals pending patent or exclusivity expiration
FDA requests for additional information or studies
Extension of Prescription Drug User Fee Amendments dates
Approval for compassionate use or expanded access programs only
Approval only for export or for use outside the United States
Emergency Use Authorization (EUA) without full approval
Complete Response Letters (CRLs) indicating the application cannot be approved in its current form

This market will immediately resolve to "No" if the FDA issues a Complete Response Letter (CRL) or explicitly declines to approve the application. If the drug sponsor withdraws the application before the end of the specified period, the market will resolve to "No" immediately.

If the listed drug is approved before the end of the specified period, the market will resolve to "Yes," regardless of potential Advisory Committee votes against approval or later withdrawal of approval.

Conditional approvals may include post-marketing requirements or commitments and still qualify.

The primary resolution source will be official information from the FDA; however, a consensus of credible reporting will also be used.
Volume
$109
Data di fine
23 apr 2026
Mercato aperto
Apr 16, 2026, 8:45 PM ET

Resolver

0x65070BE91...
As of market creation, the FDA’s expected decision date for the specified application is April 23, 2026. This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants full or conditional approval for Grace Therapeutics’ GTx-104 as a treatment for aneurysmal subarachnoid hemorrhage by May 7, 2026, 11:59 PM ET. Otherwise, this market will resolve to "No." An approval is defined as: For new drugs: FDA issuance of an approval letter for a New Drug Application (NDA) or Biologics License Application (BLA) For already-marketed drugs seeking new indications: FDA approval of a supplemental NDA (sNDA) or supplemental BLA (sBLA) for the specific indication referenced For generic drugs: FDA approval of an Abbreviated New Drug Application (ANDA) For biosimilars: FDA approval of a 351(k) application The following constitute qualifying approvals: Standard approval (traditional approval based on clinical benefit), Accelerated approval (based on surrogate endpoints), Approval with Risk Evaluation and Mitigation Strategy (REMS), Approval with restricted distribution or indication limitations, except compassionate use/expanded access programs The following do not constitute qualifying approvals: Approvable letters that require additional actions before approval Tentative approvals pending patent or exclusivity expiration FDA requests for additional information or studies Extension of Prescription Drug User Fee Amendments dates Approval for compassionate use or expanded access programs only Approval only for export or for use outside the United States Emergency Use Authorization (EUA) without full approval Complete Response Letters (CRLs) indicating the application cannot be approved in its current form This market will immediately resolve to "No" if the FDA issues a Complete Response Letter (CRL) or explicitly declines to approve the application. If the drug sponsor withdraws the application before the end of the specified period, the market will resolve to "No" immediately. If the listed drug is approved before the end of the specified period, the market will resolve to "Yes," regardless of potential Advisory Committee votes against approval or later withdrawal of approval. Conditional approvals may include post-marketing requirements or commitments and still qualify. The primary resolution source will be official information from the FDA; however, a consensus of credible reporting will also be used.

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Domande frequenti

"FDA approves Grace Therapeutics’ GTx-104?" è un mercato predittivo su Polymarket dove i trader comprano e vendono azioni "Sì" o "No" in base a se credono che questo evento accadrà. La probabilità attuale aggregata è 70% per "Yes". Ad esempio, se "Sì" è quotato a 70¢, il mercato assegna collettivamente una probabilità di 70% che questo evento si verifichi. Queste quote cambiano continuamente man mano che i trader reagiscono a nuovi sviluppi e informazioni. Le azioni nell'esito corretto possono essere riscattate per $1 ciascuna alla risoluzione del mercato.

"FDA approves Grace Therapeutics’ GTx-104?" è un mercato appena creato su Polymarket, lanciato il Apr 17, 2026. Come mercato nuovo, questa è la tua opportunità di essere tra i primi trader a stabilire le quote e i segnali di prezzo iniziali del mercato. Puoi anche aggiungere questa pagina ai preferiti per monitorare il volume e l'attività di trading man mano che il mercato guadagna visibilità.

Per fare trading su "FDA approves Grace Therapeutics’ GTx-104?", scegli semplicemente se ritieni che la risposta sia "Sì" o "No". Ogni lato ha un prezzo corrente che riflette la probabilità implicita del mercato. Inserisci il tuo importo e clicca "Trading". Se compri azioni "Sì" e l'esito si risolve come "Sì", ogni azione paga $1. Se si risolve come "No", le tue azioni "Sì" pagano $0. Puoi anche vendere le tue azioni in qualsiasi momento prima della risoluzione se vuoi consolidare un profitto o limitare una perdita.

La probabilità attuale per "FDA approves Grace Therapeutics’ GTx-104?" è 70% per "Yes". Questo significa che la comunità Polymarket attualmente ritiene che ci sia una probabilità di 70% che questo evento si verifichi. Queste quote si aggiornano in tempo reale basandosi sulle operazioni effettive, fornendo un segnale continuamente aggiornato di ciò che il mercato si aspetta accada.

Le regole di risoluzione per "FDA approves Grace Therapeutics’ GTx-104?" definiscono esattamente cosa deve accadere affinché ogni esito venga dichiarato vincitore — comprese le fonti di dati ufficiali utilizzate per determinare il risultato. Puoi consultare i criteri completi di risoluzione nella sezione "Regole" di questa pagina sopra i commenti. Ti consigliamo di leggere attentamente le regole prima di fare trading, poiché specificano le condizioni precise, i casi limite e le fonti che regolano come viene risolto questo mercato.